A Study in Reversing Hepatic Fibrosis or Cirrhosis Related to Hepatitis B Virus and Finding Biomarkers

Peking University

Status: Unknown

Conditions: Liver Fibrosis; Hepatitis B

Treatments: Drug: Anluohuaxian Pill 12g; Drug: Entecavir 0.5 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03568578

2017ZX10203202002

Details and patient eligibility

About

The aim of our study is to validate the non-invasive model which was constructed by our previous study for evaluating liver fibrosis or cirrhosis caused by hepatitis B virus in mainland China and to find a therapeutic regimen to reverse liver fibrosis and cirrhosis.

Full description

450 patients who are infected with hepatitis B virus for at least 6 months will be included in the study. They will be divided into two groups. One group will be treated with Entecavir while another treated with Entecavir and Anluohuaxian Pill. Liver biopsy samples and blood samples from the patients will be used to validate the non-invasive model. Furthermore, the samples will be used to evaluate if Anluohuaxian Pill could reverse liver fibrosis and cirrhosis.

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. HBsAg positive for at least 6 months
2. Agree to have liver biopsy
3. Male or female aged 18 to 70 years old -

Exclusion criteria

1. Patients with alcoholic liver disease, autoimmune liver disease, heretic liver disease, drug induced liver disease, nonalcoholic liver disease or other chronic liver disease
2. Platelet count < 80 × 10^9/L
3. Prothrombin activity ≤ 60%
4. Decompensated liver cirrhosis
5. Patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject -

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 2 patient groups

Entecavir Group

Active Comparator group

Description:

Patients in this arm will be given Entecavir 0.5 mg a day for 2 years.

Treatment:

Drug: Entecavir 0.5 mg

Entecavir and Anluohuaxian Group

Experimental group

Description:

Patients in this arm will be given Entecavir 0.5 mg and Anluohuaxian Pill 12 g a day for 2 years.

Treatment:

Drug: Entecavir 0.5 mg

Drug: Anluohuaxian Pill 12g